FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR

K Number: K884413 · Decision Dec 2, 1988
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
6
Applicant Total
94
Review Days
43

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Basic Information

Device Name
CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR
K Number
K884413
Device Class
FDA unclassified
Clearance Type
Traditional
Medical Specialty
Unknown
Decision
Substantially Equivalent
Applicant
Valleylab, Inc.
Date Received
October 20, 1988
Decision Date
December 2, 1988
Product Code
LBK
Advisory Committee
Unknown
Review Advisory Committee
NE
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
LBK Neurosurgical Ultrasonic Instruments

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Other Clearances by Valleylab, Inc.

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K010013 LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100
K994428 E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODE
K983743 BISURE LAPAROSCOPIC BIPOLAR FORCEPS
K981916 LIGASURE VESSEL SEALING SYSTEM
K981262 CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM
K980915 VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM
K970140 E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCH
K964636 FORCE ARGON II ARGON ENHANCED ELECTROSURGICAL SYSTEM
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